Cell Process Development

Job Code: CPD-SCI

 We are currently seeking an experienced professional to fill a role
in Cell Process Development. This position will conduct and manage the
activities related to the Company’s cell isolation and cell culture
process development.

In the Cell Process Development role, you will:

• Transfer tissue processing, cell culture processes and candidate assays from research, perform pilot plant scale operations, and evaluate existing processes to improve yield and/or throughput
• Troubleshoot, develop, and perform pilot plant scale operations, and evaluate existing processes to improve yield and/or throughput
• Design and perform process validation, stability, and comparability studies
• Be responsible for the successful transfer of processes to manufacturing and/or collaborators for use in clinical trial production
• Collaborate with Research to confirm product function following process changes
• Develop and implement protocols, reports, SOPs, and formulation and process development documents to support regulatory filings as needed
• Independently develop and implement solutions
• Serve as a thought leader and key member of cross functional project teams

 Additionally, as a member of the R&D team, you must also:

• Stay abreast of recent developments from the discovery scientists to facilitate the translation to development and manufacturing
• Be set up to perform qualification and validation studies
• Address regulatory and compliance issues as part of the transition, specifically in regard to product quality, manufacturing, and facilities issues
• Generate or review technical projects, assay evaluations, stability studies, and investigations
• Lead projects and provide guidance or training as required to other team members
• Collaborate with Project Management to meet regulatory and project deadlines

Education, Experience and Skill Requirements:

• An advanced degree in biology, bioengineering, or related engineering discipline
• A minimum of 5 years biotech experience
• A solid understanding of cell process and cell culture techniques for primary cells and mammalian cell culture outside of the hybridoma field
• Knowledge of cGMP cell culture processes, equipment, closed systems, cryropreservation techniques, and cell based assays
• A thorough understanding of regulatory/compliance issues related to product quality, manufacturing, and cell processing facilities
• Demonstrated ability to apply engineering principles to design and problem solving
• A proven track record managing projects, personnel, and timelines

To Apply:

Be sure to indicate the title or job code of the position you are applying for.

 Email resume (MS Word, Adobe PDF or plain text only) to: staffing@stemcellsinc.com

Fax resumes to: 650.475.3101

Mail resume to:
StemCells,Inc.,
Attn.: Staffing
3155 Porter Drive
Palo Alto, CA 94304